Product Release & QA Documentation Coordinator

FUJIFILM Holdings America Corporation; Dyer (CA); On-site; USD 36,000 - 40,000; Full time

Benefits offered by this job

Medical, Dental, Vision

Life Insurance

401k

Paid Time Off

Job summary

FUJIFILM Biosciences in California seeks a Product Release Coordinator to ensure product quality through batch record reviews, create and sign Certificate of Analysis, and verify return goods. The role covers document control, device history records, and internal audits in a fast-paced QA environment.

Requirements include a high school diploma, 2+ years in QA for medical devices, and familiarity with ISO13485 and FDA QSR. On-site with benefits such as medical and 401k support.

Qualifications

• High school diploma or equivalent.
• Two years of college in a science discipline preferred.
• Minimum two years of QA in medical device manufacturing or equivalent.
• Proficiency in WordPerfect, MS Word, Excel, Outlook.
• Knowledge of 21CFR211-cGMP, FDA QSR 820, ISO13485:2003 and related guidelines.
• English speaking, reading and writing ability.
• Strong communication skills.

Responsibilities

• Review and verify batch records and QA Final Release History.
• Create and maintain database for Certificate of Analysis.
• Review and process Return Goods Authorizations.
• Inspect labeling and storage conditions of products.
• Maintain non-conforming material log and files.
• Assist in preparing controlled documents (generate DCRs).
• Review and improve processes; provide training as needed.
• Maintain Device History Records files and database.
• Perform internal audits as needed.
• Assist Document Control department as needed.
• Collaborate with departments to meet customer requests.
• Lot folder scanning.

Skills

Math

Chemistry

Science courses

Quality Assurance

Word

Excel

Outlook

WordPerfect

Education

High school diploma

Science courses (2 years college)

QA experience (2+ years)

Tools

WordPerfect

MS Word

Excel

Outlook

Job description

FUJIFILM Biosciences in California seeks a Product Release Coordinator to ensure product quality through batch record reviews, create and sign Certificate of Analysis, and verify return goods. The role covers document control, device history records, and internal audits in a fast-paced QA environment.

Requirements include a high school diploma, 2+ years in QA for medical devices, and familiarity with ISO13485 and FDA QSR. On-site with benefits such as medical and 401k support.